Active ingredient
Albuterol
130 finished FDA listings contain Albuterol as their only active ingredient; 19 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- ALBUTEROL, ALBUTEROL SULFATE
- Dosage forms
- Aerosol, Metered, Inhalant, Powder, Metered, Solution, Syrup, Tablet
- Routes
- Oral, Respiratory (Inhalation)
- Manufacturers / labelers
- 46
- Strengths listed
- .63 mg/3ml · .83 mg/ml · 1.25 mg/3ml · 108 ug/1 · 2 mg/1 · 2 mg/5ml · 2.5 mg/.5ml · 2.5 mg/3ml · 4 mg/1 · 90 ug/1
- Brand names in FDA listings
- Albuterol, Albuterol Sulate Hfa, Albuterol Sulfate Hfa, Albuterol Sulfate Inhalation, Albuterol Sulfate Inhalation Solution, Albuterol Sulfate Inhalation Solution, 0.5%, Proair Digihaler, Proair Respiclick, Ventolin Hfa
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 435
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 072637 | SUN PHARM INDUSTRIES | 1989-02-01 | 5 |
| ANDA 072151 | CHARTWELL RX | 1989-03-23 | 2 |
| NDA 020503 | KINDEVA | 1996-08-15 | 4 |
| ANDA 074880 | NEPHRON | 1997-09-17 | 12 |
| NDA 020983 | GLAXOSMITHKLINE | 2001-04-19 | 14 |
| ANDA 075664 | NEPHRON | 2001-06-26 | 3 |
| ANDA 076355 | NEPHRON | 2004-06-28 | 6 |
| NDA 021457 | TEVA BRANDED PHARM | 2004-10-29 | 4 |
| ANDA 077788 | CHARTWELL RX | 2007-06-26 | 2 |
| ANDA 077839 | RITEDOSE CORP | 2008-12-16 | 9 |
| NDA 205636 | TEVA BRANDED PHARM | 2015-03-31 | 2 |
| ANDA 207857 | SUN PHARM | 2017-07-21 | 4 |
| ANDA 206224 | LUOXIN AUROVITAS | 2017-10-17 | 3 |
| ANDA 208804 | AMNEAL PHARMS CO | 2018-05-21 | 2 |
| ANDA 207046 | RISING | 2018-06-29 | 5 |
| ANDA 212197 | QUAGEN | 2019-09-06 | 4 |
| ANDA 203760 | PADAGIS US | 2020-02-24 | 4 |
| ANDA 209959 | CIPLA | 2020-04-08 | 6 |
| ANDA 211888 | LUOXIN AUROVITAS | 2020-04-20 | 4 |
| ANDA 213657 | AUROBINDO PHARMA LTD | 2020-05-14 | 2 |
| ANDA 209954 | LUPIN | 2020-08-24 | 9 |
| ANDA 208884 | ZYDUS PHARMS | 2020-10-22 | 4 |
| ANDA 207085 | SANDOZ | 2021-06-01 | 7 |
| ANDA 214531 | RITEDOSE CORP | 2021-12-28 | 4 |
| ANDA 215571 | LEXENPHARM | 2024-05-03 | 2 |
| ANDA 212447 | ARMSTRONG PHARMS | 2024-05-21 | 4 |
| ANDA 218386 | RITEDOSE CORP | 2025-03-12 | 1 |
| ANDA 211600 | AMNEAL IRELAND LTD | 2025-12-01 | 1 |
| ANDA 219409 | CIPLA | 2026-04-22 | 1 |
Official labeling on DailyMed
- ALBUTEROL SULFATE INHALANT [ARMSTRONG PHARMACEUTICALS, INC.] · version 5 · 2026-08-10
- ALBUTEROL SULFATE AEROSOL, METERED [NUCARE PHARMACEUTICALS, INC.] · version 1 · 2026-08-06
- ALBUTEROL SULFATE SOLUTION [RISING PHARMA HOLDINGS, INC.] · version 3 · 2026-07-30
- ALBUTEROL SULFATE SOLUTION [RISING PHARMA HOLDINGS, INC.] · version 3 · 2026-07-30
- ALBUTEROL SULFATE SOLUTION [RISING PHARMA HOLDINGS, INC] · version 3 · 2026-07-30
- ALBUTEROL SULFATE AEROSOL, METERED [HAWAII REPACK, INC.] · version 1 · 2026-07-10
- VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REMEDYREPACK INC.] · version 14 · 2026-07-06
- ALBUTEROL SOLUTION [MYLAN PHARMACEUTICALS INC.] · version 3 · 2026-06-26
- ALBUTEROL SULFATE SOLUTION [AMERICAN HEALTH PACKAGING] · version 5 · 2026-06-24
- ALBUTEROL SULFATE SOLUTION [REMEDYREPACK INC.] · version 7 · 2026-06-18
- ALBUTEROL SULFATE INHALANT [CIPLA USA INC.] · version 11 · 2026-06-18
- ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS INC.] · version 4 · 2026-06-11
Showing the 12 most recent of 103 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.